IleostomyNCT05915052

B-suture Ileostomy in Clinical Practice: a Retrospective, Single-center, Propensity Score-matched Study

A study testing B-type suture ileostomy and the traditional ileostomy in people with Ileostomy and Ileostomies, run by Northern Jiangsu People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

OBJECTIVE: The purpose of this study was to introduce a new temporary ileostomy modality, the B-suture ileostomy, and to compare its technical advantages in comparison with conventional ileostomy. Read more about this study

Who is it for?: Any age
Conditions the study is for: Ileostomy, Ileostomies, Loop Ileostomies
What is being tested?: B-type suture ileostomy and the traditional ileostomy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 185 participants
Where: 1 siteChina
Study dates: 1 Jan 2018to 6 Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

If necessary, combine bulleted, numbered, and lettered lists in order to create lists within a list. For example:simultaneous laparoscopic low anterior resection of rectal cancer + temporary ileostomy;
pathologically confirmed primary rectal cancer;
rectal tumor height ≤12 cm from the anal verge;
no tumor metastasis at the time of surgical resection;
all surgeries were performed by the same surgical team with more than 10 years of experience in laparoscopic radical resection of rectal cancer and ileostomy.

Who cannot join

patients who did not undergo stoma rejection due to tumor metastasis or recurrence;
patients who were too old or in poor general condition to undergo stoma reversal surgery;
patients with multiple primary colorectal cancers who underwent simultaneous multifocal resection;
patients with incomplete clinical medical information.

Trial locations and contacts

1 site in 1 country.

China1 site

Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001

Other trials in China

About this study

Official title: A New Type of Temporary Ileostomy --B-suture Ileostomy Applied to Laparoscopic Low Anterior Rectal Resection

OBJECTIVE: The purpose of this study was to introduce a new temporary ileostomy modality, the B-suture ileostomy, and to compare its technical advantages in comparison with conventional ileostomy.

CONCLUSION: This study shows that B-suture ileostomy can simplify the surgical procedure, facilitate learning and promotion, shorten the stoma and surgical time, can reduce complications such as irritant dermatitis, peristoma infection, stoma stricture, stoma retraction, shorten the hospital stay, reduce postoperative pain, and is similar to the traditional procedure in terms of secondary surgical return, which is a surgical procedure worth continuing to explore.

Read the detailed description

OBJECTIVE: The purpose of this study was to introduce a new temporary ileostomy modality, the B-suture ileostomy, and to compare its technical advantages in comparison with conventional ileostomy.

METHODS: A retrospective single-center study analyzed 185 patients undergoing laparoscopic low anterior resection for rectal cancer combined with temporary ileostomy, collecting general case data, surgery-related data, postoperative-related complications, secondary surgical return data, and postoperative health status data, and divided into a B-suture ileostomy group (n=62) and a conventional method ileostomy group (n=123) according to the different stoma methods, by propensity score matching (pSM) for 1:1 matching (n=59 for both groups after matching). The advantages and disadvantages of the B-suture method ileostomy were evaluated by analyzing and comparing information on the perioperative period, postoperative related complications, and postoperative health status.

Conditions: Ileostomy, Ileostomies, Loop Ileostomies
Being tested: B-type suture ileostomy, the traditional ileostomy
Keywords: Loop Ileostomies, ileostomy, traditional, laparoscopic low anterior rectal resection, complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

B-type suture ileostomyProcedure or surgery
Type B suture stoma group：2-0 stitched sutures were placed in the center of the incision, from the anterior rectus sheath on the left side of the incision → the posterior rectus sheath on the left side of the incision → through the avascular area below the vascular arch at the mesenteric border of the ileum to the contralateral side → the posterior rectus sheath on the right side of the incision → the anterior rectus sheath on the right side of the incision→ the posterior rectus sheath on the right side of the incision → through the avascular area below the vascular arch at the mesenteric border of the ileum to the contralateral side → the posterior rectus sheath on the left side of the incision →the anterior rectus sheath on the left side of the incision sutures were sewn through in the sequence, tightened and knotted .
the traditional ileostomyProcedure or surgery
Then take the right lower abdominal incision to cut a circular incision of 3 cm in diameter, round excision of subcutaneous fat, cross incision of rectus sheath and peritoneum, enter the abdomen, raise the marked ileum out of the body, interrupt suture of ileum with peritoneum and posterior sheath of rectus abdominis for one week, then interrupt suture of ileum with anterior sheath of rectus abdominis for one week, transverse incision of 2 cm in diameter, interrupted with 3-0 absorbable thread, The ileocecal incision and the skin of the right lower abdominal circular incision were sutured for one week to complete the double-lumen stoma at the end of the ileum.

Study groups in NCT05915052
Study group	Role	What they receive
the B-type suture ileostomy group	Active comparator	the B-type suture ileostomy group underwent laparoscopic low anterior resection and a B-type suture ileostomy Receives: Procedure: B-type suture ileostomy
the traditional ileostomy group	Active comparator	the traditional ileostomy group underwent laparoscopic low anterior resection and a traditional ileostomy Receives: Procedure: the traditional ileostomy

What is being measured

The primary outcome is the main question the study is designed to answer.

total operative time
the operating time of the two groups
Measured: one year
ileostomy time
time spent on ileostomies by the two groups
Measured: one year
bleeding volume
Intraoperative bleeding in both groups
Measured: one year
time of stoma evacuation
time of stoma evacuation for the two groups
Measured: one year
time of starting to eat
time of starting to eat in both groups
Measured: one year
time to first ambulation
time to first ambulation in both groups
Measured: one year
postoperative hospital stay
postoperative hospital stay in both groups
Measured: one year

Secondary outcomes (1)

Complications related to the stoma
Complications related to the stoma in both groups，such as irritant dermatitis、Parastomal hernia、Incisional hernia、Intestinal obstruction、Stoma bleeding Peristomal infection、Infection of specimen 、removal incision、Stoma stenosis、Stoma retraction、Stoma prolapse、Dehydration
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20186 Jun 2023

First posted22 Jun 2023
Study start1 Jan 2018
Primary completion31 Dec 2022
Study completion6 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for IleostomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: To minimize bias in baseline characteristics between the B-suture stoma group and the conventional method stoma group, we performed propensity score matching (pSM) with a matching tolerance (M) set at 0.02 and nearest neighbor matching without put-back at a ratio of 1:1. Baseline information for matching was: gender, age, BMI, hemoglobin, albumin, diabetes, hypertension, previous abdominal surgery history, distance of the lower margin of the tumor from the anal margin, tumor diameter, American Society of Anesthesiology (ASA) physical classification, and tumor stage. 62 patients in the B-suture stoma group were successfully matched 1:1 with 123 patients in the conventional stoma group to 59 patients in the B-suture stoma group and 59 patients in the conventional stoma group. 59 patients in the B-stitch stoma group and 59 patients in the conventional stoma group.
Masking: None (open label)
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05915052
Sponsor's protocol ID: NorthernJiangsu002
Status last verified: Apr 2024
First submitted: 5 Jun 2023
Last updated: 18 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sun L, Zhou J, Ji L, Wang W, Zhang Q, Qian C, Zhao S, Li R, Wang D. Clinical application of the B-type sutured ileostomy in robotic-assisted low anterior resection for rectal cancer: a propensity score matching analysis. J Robot Surg. 2024 Apr 5;18(1):159. doi: 10.1007/s11701-024-01924-8.
PubMed 38578352

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
Ulcerative Colitis, Ileal Pouch
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Active, not recruitingPhase 2
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
Crohn's Disease
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula

All Ileostomy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A New Type of Temporary Ileostomy --B-suture Ileostomy Applied to Laparoscopic Low Anterior Rectal Resection
ClinicalTrials.gov ID: NCT05915052
Acronym / sponsor ID: NorthernJiangsu002
Conditions: Ileostomy, Ileostomies, Loop Ileostomies
Keywords: Loop Ileostomies, ileostomy, traditional, laparoscopic low anterior rectal resection, complications
Study type: Interventional
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: Northern Jiangsu People's HospitalUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 6 Jun 2023 (actual)
First posted: 22 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

OBJECTIVE: The purpose of this study was to introduce a new temporary ileostomy modality, the B-suture ileostomy, and to compare its technical advantages in comparison with conventional ileostomy.

Detailed description

OBJECTIVE: The purpose of this study was to introduce a new temporary ileostomy modality, the B-suture ileostomy, and to compare its technical advantages in comparison with conventional ileostomy.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: To minimize bias in baseline characteristics between the B-suture stoma group and the conventional method stoma group, we performed propensity score matching (pSM) with a matching tolerance (M) set at 0.02 and nearest neighbor matching without put-back at a ratio of 1:1. Baseline information for matching was: gender, age, BMI, hemoglobin, albumin, diabetes, hypertension, previous abdominal surgery history, distance of the lower margin of the tumor from the anal margin, tumor diameter, American Society of Anesthesiology (ASA) physical classification, and tumor stage. 62 patients in the B-suture stoma group were successfully matched 1:1 with 123 patients in the conventional stoma group to 59 patients in the B-suture stoma group and 59 patients in the conventional stoma group. 59 patients in the B-stitch stoma group and 59 patients in the conventional stoma group.

Arm	Type	Receives
the B-type suture ileostomy group	Active comparator	Procedure: B-type suture ileostomythe B-type suture ileostomy group underwent laparoscopic low anterior resection and a B-type suture ileostomy
the traditional ileostomy group	Active comparator	Procedure: the traditional ileostomythe traditional ileostomy group underwent laparoscopic low anterior resection and a traditional ileostomy

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

If necessary, combine bulleted, numbered, and lettered lists in order to create lists within a list. For example:simultaneous laparoscopic low anterior resection of rectal cancer + temporary ileostomy;
pathologically confirmed primary rectal cancer;
rectal tumor height ≤12 cm from the anal verge;
no tumor metastasis at the time of surgical resection;
all surgeries were performed by the same surgical team with more than 10 years of experience in laparoscopic radical resection of rectal cancer and ileostomy.

Key exclusion criteria (4 listed)

patients who did not undergo stoma rejection due to tumor metastasis or recurrence;
patients who were too old or in poor general condition to undergo stoma reversal surgery;
patients with multiple primary colorectal cancers who underwent simultaneous multifocal resection;
patients with incomplete clinical medical information.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
B-type suture ileostomyType B suture stoma group：2-0 stitched sutures were placed in the center of the incision, from the anterior rectus sheath on the left side of the incision → the posterior rectus sheath on the left side of the incision → through the avascular area below the vascular arch at the mesenteric border of the ileum to the contralateral side → the posterior rectus sheath on the right side of the incision → the anterior rectus sheath on the right side of the incision→ the posterior rectus sheath on the right side of the incision → through the avascular area below the vascular arch at the mesenteric border of the ileum to the contralateral side → the posterior rectus sheath on the left side of the incision →the anterior rectus sheath on the left side of the incision sutures were sewn through in the sequence, tightened and knotted .	Procedure or surgery	the B-type suture ileostomy group
the traditional ileostomyThen take the right lower abdominal incision to cut a circular incision of 3 cm in diameter, round excision of subcutaneous fat, cross incision of rectus sheath and peritoneum, enter the abdomen, raise the marked ileum out of the body, interrupt suture of ileum with peritoneum and posterior sheath of rectus abdominis for one week, then interrupt suture of ileum with anterior sheath of rectus abdominis for one week, transverse incision of 2 cm in diameter, interrupted with 3-0 absorbable thread, The ileocecal incision and the skin of the right lower abdominal circular incision were sutured for one week to complete the double-lumen stoma at the end of the ileum.	Procedure or surgery	the traditional ileostomy group

Primary outcome

total operative time
Time frame: one year
the operating time of the two groups
ileostomy time
Time frame: one year
time spent on ileostomies by the two groups
bleeding volume
Time frame: one year
Intraoperative bleeding in both groups
time of stoma evacuation
Time frame: one year
time of stoma evacuation for the two groups
time of starting to eat
Time frame: one year
time of starting to eat in both groups
time to first ambulation
Time frame: one year
time to first ambulation in both groups
postoperative hospital stay
Time frame: one year
postoperative hospital stay in both groups

1 secondary outcome

Complications related to the stoma
Time frame: one year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
Derived from this study: PubMed 38578352Sun L, Zhou J, Ji L, Wang W, Zhang Q, Qian C, Zhao S, Li R, Wang D. Clinical application of the B-type sutured ileostomy in robotic-assisted low anterior resection for rectal cancer: a propensity score matching analysis. J Robot Surg. 2024 Apr 5;18(1):159. doi: 10.1007/s11701-024-01924-8.
Individual participant dataSharing planned: No

Related trials for Ileostomy

RecruitingPhase 2
Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
Ulcerative Colitis, Ileal Pouch
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Active, not recruitingPhase 2
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
Crohn's Disease
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

sun longhe, Master principal investigator

https://www.yzsbh.com/

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing B-type suture ileostomy and the traditional ileostomy in people with Ileostomy and Ileostomies, run by Northern Jiangsu People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

total operative time (time frame: one year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05915052, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.